NCT03347357

Brief Summary

the present study was conducted to assess the population pharmacokinetics of tacrolimus in children with nephrotic syndrome and to use these data to calculate an optimal dosing regimen of tacrolimus for use in these patients.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 30, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
Last Updated

November 20, 2017

Status Verified

October 1, 2017

Enrollment Period

5.8 years

First QC Date

October 30, 2017

Last Update Submit

November 17, 2017

Conditions

Nephrotic Syndrome

Outcome Measures

Primary Outcomes (1)

  • change of plasma concentration of Tacrolimus

    To detect the plasma concentrations of Tacrolimus after oral administration

    at 1,2,3,6,9,12 hours after oral administration

Study Arms (1)

tacrolimus

EXPERIMENTAL
Drug: Tacrolimus

Interventions

TacrolimusDRUG

Tacrolimus was administered orally at a dose of 0.05 mg/kg/dose twice daily (bid) for children with nephrotic syndrome.

tacrolimus

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patients have been diagnosed with nephrotic syndrome;
  • age range: 1 month to 18 years old
  • tacrolimus used as part of regular treatment

You may not qualify if:

  • expected survival time less than the treatment cycle;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Nephrotic Syndrome

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

NephrosisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Wei Zhao, Ph.D

    Shandong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of department of clinical pharmacy and pharmacology

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 20, 2017

Study Start

January 1, 2012

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

November 20, 2017

Record last verified: 2017-10